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COMPLETEDPHASE1/PHASE2

Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of Coronavirus Disease 2019 (COVID-19)

A Phase I/II Single-Blinded Randomised Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of COVID-19

NCT04760730•R-Pharm

View on ClinicalTrials.gov

Summary

This is a Phase I/II, parallel group, single blinded (participant blinded), randomised study assessing the immunogenicity and safety of AZD1222 and rAd26-S administered as heterologous prime-boost in alternating order in 2 study groups for the Prevention of COVID-19.

Detailed Description

This is a prospective, single blinded randomised clinical study, designed to provide data on the heterologous prime boost use of AZD1222 and rAd26-S, to be administered one after the other interchangeably. This study aims to explore the immunogenicity and safety of combining these 2 different adenovirus vector vaccines in the prevention of coronavirus disease 2019 (COVID-19). Participants will be healthy adults ≥ 18 years of age. Approximately 100 participants will be randomised (1:1) to one of the following groups: * Group A: 1 intramuscular (IM) injection of 5×10\^10 vp (nominal) of AZD1222 on Day 1 followed by rAd26-S (1.0±0.5) х 10\^11vp (nominal) on Day 29. * Group B: 1 IM injection of rAd26-S (1.0±0.5) х 10\^11vp (nominal) on Day 1 followed by AZD1222 5×10\^10 vp (nominal) on Day 29. Immunogenicity will be assessed for the duration of the study, including serologic quantification of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) antigen specific antibody levels and antibody seroconversion rate, neutralising antibody assays and cellular immunity testing. Safety will be assessed for the duration of the study as follows: * Solicited adverse events (AEs) (local and systemic) will be assessed for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination). * Unsolicited AEs will be recorded for 29 days following each vaccination (ie, until Day 29 following the first vaccination and Day 57 following the second vaccination). * Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 180. However, the safety endpoint for SAEs will be assessed after the first vaccination (see Section 12.2). * Adverse events of special interest (AESIs) will be recorded from first vaccination through Day 180. This study is going to be conducted in the United Arab Emirates. All participants will remain on study for 6 months (180 days) following the first vaccination.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1. Participants are:
•* Overtly healthy as determined by medical evaluation, or
•* Medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow up.
•(A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment.)
•2. Able to understand and comply with study requirements/procedures based on the assessment of the investigator.
•3. Female participants
•1. Women of childbearing potential must:
•* Have a negative pregnancy test on the day of screening and on Day 1
•* Use one highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Periodic abstinence, the rhythm method, and withdrawal are NOT acceptable methods of contraception.
+8 more criteria

Exclusion Criteria

•1. Known past laboratory-confirmed SARS-CoV-2 infection less than 6 month prior to screening (the date of diagnosis must be confirmed by an official document).
•2. Positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) reverse transcription-polymerase chain reaction (RT-PCR) test at screening.
•3. Significant infection or other illness, including fever \> 37.8°C on the day prior to or day of randomisation.
•4. Any confirmed or suspected immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection; asplenia; recurrent severe infections and use of chronic immunosuppressant medication within the past 6 months (≥ 20 mg/day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to vaccination), except topical/inhaled steroids or short term oral steroids (course lasting ≤ 14 days).
•1. Note: HIV-positive participants with CD4 counts \> 500 for ≥ 12 months and on a stable HIV antiretroviral regimen may be enrolled.
•2. Note: Topical tacrolimus is allowed if not used within 14 days prior to the day of enrolment.
•5. History of allergy to any component of the vaccine.
•6. Any history of anaphylaxis or angioedema.
•7. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ).
•8. History of serious psychiatric condition likely to affect participation in the study.
+19 more criteria

Locations (1)

Tawam Hospital

Al Ain City, United Arab Emirates

Key Dates

Start Date

July 13, 2021

Primary Completion Date

March 29, 2022

Completion Date

July 26, 2022

Last Updated

October 26, 2022

Enrollment

100

ACTUAL participants

Conditions

COVID-19

Interventions

AZD1222

BIOLOGICAL

rAd26-S

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of Coronavirus Disease 2019 (COVID-19)

Inclusion Criteria

Exclusion Criteria

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